A Playbook for MedTech Success

FDA scrutiny, financial pressures, and M&A inefficiencies push MedTech leaders to prioritise short-term issues over long-term strategies
Balancing short-term compliance with long-term strategic planning is crucial for survival
Innovation hubs, agile methodologies, customer engagement, and cross-functional teams are key to future growth and competitive advantage

In December 2023, FDA compliance leaders convened at a conference hosted by the US Food and Drug Law Institute (FDLI) in Washington, DC, to discuss the year’s trends and plans for 2024. Keisha Thomas, the FDA’s Associate Director for Compliance and Quality, highlighted key issues from 2023, reporting that 89 inspections had identified violations requiring Corrective and Preventive Actions (CAPAs). Additionally, there were 790 device recalls, and ~70% of 28 device warning letters were associated with the use of unapproved devices. Thomas emphasised that in 2024, the FDA would target companies with a record of repeated infringements, “We’re developing strategies for addressing companies that are in and out of compliance within a short period of time,” she said. By June 5, 2024, the FDA had issued >45 recalls for medical devices.

Regulatory breaches arise from factors such as non-compliance, quality control issues, incomplete documentation, insufficient testing, inadequate risk management, poor communication and training, delayed reporting, lack of post-market surveillance, design failures, supply chain issues, and failure to implement corrective actions. Effective management of these issues requires comprehensive diligence.

However, these process-oriented challenges often do not receive the attention they require for optimal integration following acquisitions. MedTech companies have historically relied on mergers and acquisitions (M&A) as their primary growth strategy. While this approach has typically resulted in financial gains and increased company size, it has not always improved operational efficiency or quality. The financial complexities of M&A transactions often consume company resources, leading to insufficient attention to critical non-financial operational processes, which can increase the risk of non-compliance with FDA regulations.

To tackle these challenges, companies should prioritise digitising their production processes to boost operational efficiency and compliance, ensuring that growth does not compromise quality or safety. Heightened FDA scrutiny can divert resources from integration and process improvements to remediation efforts, which can be detrimental in a rapidly evolving healthcare landscape marked by advancing technologies and increasing investor scepticism.

Over the next decade, traditional companies must undergo transformations to generate new value for patients and shareholders. This requires rebuilding robust supply chains and leveraging the benefits of digitisation and Industry 4.0. Companies should be able to address FDA warning letters, while redesigning manufacturing and distribution networks, improving flexibility, driving innovation, and expanding market access. To support these initiatives, a strategic playbook is essential for driving growth, enhancing value, and boosting competitive advantage. Leaders must balance short-term compliance with forward-looking strategies to ensure long-term success.

In this Commentary

This Commentary provides a guide for MedTech leaders navigating the rapidly evolving healthcare ecosystem. It highlights key challenges such as heightened FDA scrutiny, financial pressures, and operational inefficiencies often resulting from sub-optimal M&A integration. The discussion underscores the importance of balancing short-term compliance with long-term strategic planning to sustain growth and maintain competitive advantage. Key strategies include continuous investment in research and development (R&D), integrating digital health solutions, and ensuring regulatory compliance. The Commentary also emphasises the need for enhancing patient-centric solutions, forming strategic partnerships, and maintaining robust talent acquisition and retention practices. Leaders are encouraged to adopt agile methodologies, establish innovation hubs, and leverage cross-functional teams to drive progress and improve market responsiveness. By focusing on these strategic areas, MedTech companies can foster creativity, enhance customer engagement, and ensure sustained growth in the dynamic healthcare landscape.

Key Drivers of Growth, Value, and Competitive Advantage

Technological Innovation and Integration
Technologically stagnant companies are unstable and prone to failure. Over time, they lose their ability to innovate and address challenges, ultimately leading to their downfall. To stay competitive, MedTech leaders must navigate rapid technological changes, particularly in AI, machine learning (ML), and personalised care. These advancements are transforming diagnostics, treatment, and patient journeys, making continuous innovation essential for increasing growth, enhancing value, and bolstering competitiveness.

Software has become a critical growth driver for companies. This shift requires adopting new approaches to product development and operating models like those of tech companies. Key strategies include: (i) building a resilient solutions stack with engagement, intelligence, and infrastructure layers, (ii) adopting best practices in software development, including reimagining product management, and (iii) strategically sourcing intellectual property (IP) and talent.

Integrating innovative technologies into traditional product lines is essential yet challenging, as it requires new skill sets, robust IT infrastructure, and strategic partnerships with tech firms. This approach can enhance patient engagement, improve outcomes, and streamline healthcare delivery.

Success in technology innovation and integration hinges on merging traditional medical expertise with cutting-edge digital innovations. Healthcare professionals must compliment their medical knowledge with an understanding of technological advancements. Leveraging digital tools like electronic health records, telehealth platforms, and AI enhances patient care. Such integration creates a blend of human expertise and digital innovation, leading to improved patient outcomes, efficient processes, and a more responsive healthcare system.

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Regulatory and Compliance Pressures
Navigating the regulatory landscapes, such as obtaining FDA approval in the US and CE marking in the EU, is both time-consuming and costly. These processes require meticulous documentation, rigorous testing, and continuous compliance, often delaying product launches and increasing expenses. Moreover, ensuring compliance with data privacy laws, such as GDPR in Europe and HIPAA in the US, while leveraging patient data for innovation presents another layer of complexity. Balancing the need for data-driven innovation with stringent privacy and security requirements demands robust data governance frameworks and advanced cybersecurity measures. Enterprises must invest in technologies and practices that protect patient information while still allowing for meaningful data analysis and use. Successfully managing these regulatory and compliance hurdles is critical for maintaining trust, achieving market access, and fostering innovation.

Market Dynamics and Competition
Large traditional MedTechs face increasing competition from both peers and start-ups. Every year, start-ups introduce new solutions to the market, often leveraging disruptive technologies and streamlined processes that outpace conventional approaches. To remain competitive, established companies must enhance their agility and speed to market while continuously innovating their product offerings.

Expanding into global markets, particularly emerging ones introduces additional obstacles. These markets come with distinct regulatory requirements, unique social and commercial norms, and varied healthcare infrastructures, leading to strategic and operational challenges. Successfully entering and thriving in these regions necessitates an understanding of local regulations, effective partnerships with regional entities, and tailored strategies that address the unique healthcare needs and economic conditions of each market. Navigating these dynamics and competitive pressures, enables MedTechs to unlock new growth opportunities and strengthen their global presence.

Cost Management and Efficiency
There are ongoing challenges associated with managing rising expenses. These include expenditures on R&D to stay ahead of technological advancements, costs related to recruiting, developing, and retaining top talent, regulatory compliance to meet stringent global standards, and manufacturing expenses. Balancing these financial demands while maintaining profitability requires strategic planning and resource allocation.

Enhancing operational efficiency is important to reduce costs and improve margins without compromising on quality or innovation. This involves streamlining processes, adopting advanced manufacturing techniques, and leveraging automation and digital technologies to optimise production. Additionally, implementing lean management practices can help eliminate waste, reduce lead times, and improve overall productivity. Emphasising cost management and operational efficiency allows companies to maintain their competitive edge, ensuring the efficient and sustainable delivery of high-quality, innovative products to the market.

Customer Expectations and Experience
In the evolving healthcare landscape meeting rising customer expectations has become an imperative. This has partly been driven by the shift towards more patient-centric solutions, which necessitates an understanding of patient needs and preferences, enabling companies to deliver personalised solutions and services that enhance outcomes and satisfaction. Embracing this approach requires robust data analytics and feedback mechanisms to ensure that products and services are aligned with customer expectations.

Equally important is the strengthening of relationships with providers. Effective collaboration with healthcare professionals is essential for the successful adoption and utilisation of new technologies and products. Companies should focus on creating strong partnerships, offering comprehensive training, support, and integrating their technologies into clinical workflows. Cultivating these relationships ensures that MedTech' innovations are effectively implemented, ultimately improving patient care and operational efficiencies.

Talent Acquisition and Retention
MedTechs face obstacles in attracting and retaining a skilled workforce, particularly in specialised areas such as AI, ML, and data analytics. The rapid advancements in these fields necessitate the recruitment of highly qualified professionals who can drive innovation and maintain competitive advantage. A 2023 McKinsey report suggested that demand for individuals with data science and natural-language processing skills is outpacing supply. To stand a chance of recruiting and retaining data scientist successfully, it is crucial for corporations to offer compelling incentives, continuous learning opportunities, and career advancement pathways.

Equally important is cultivating a corporate culture that supports innovation, collaboration, and agility. In an industry historically characterised by slow-moving processes, fostering a dynamic and forward-thinking environment is essential. This involves encouraging cross-functional teamwork, embracing new ideas, and being responsive to market changes. Developing a culture that values creativity and flexibility enhances companies' ability to adapt to emerging trends, attracts top talent, and retains key employees motivated to drive long-term success.

Partnerships and Collaborations
Forming strategic partnerships is crucial for driving innovation and accessing new markets. Corporations must collaborate with technology companies, start-ups, and research institutions to leverage cutting-edge advancements and diversify their product offerings. Such partnerships can provide access to disruptive technologies, foster co-development opportunities, and facilitate entry into emerging markets, thereby enhancing the company's growth potential and competitive edge.

Additionally, strategically managing M&A is important for integrating new technologies and capabilities. This requires a balance to ensure that the integration of new assets does not disrupt existing operations. Companies must develop robust integration strategies that preserve the value of acquired entities while blending them into the corporate structure. This approach enhances MedTechs' technological capabilities and market reach, ultimately strengthening their industry position and driving sustained innovation and growth.

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Sustainability and Social Responsibility
Sustainability and social responsibility are increasingly important challenges for traditional corporations. Adopting sustainable practices in manufacturing and operations is essential to meet both regulatory requirements and stakeholder expectations for environmental responsibility. This involves reducing carbon footprints, minimising waste, and ensuring the responsible use of resources throughout the product lifecycle. Companies that prioritise sustainability can enhance their brand reputation and appeal to a growing segment of environmentally conscious consumers and employees.

Ethical considerations also play a role, particularly in areas such as AI in healthcare, data usage, and informed consent. As AI technologies become integrated into medical devices and healthcare systems, enterprises must ensure that these tools are developed and deployed ethically. This involves safeguarding patient data, ensuring transparency in AI decision-making processes, and obtaining informed consent from patients. Addressing these challenges proactively can build trust with stakeholders and ensure compliance with evolving legal and regulatory standards, ultimately fostering a more responsible and sustainable industry.

Funding and Investment
Securing sufficient funding for R&D can be an issue for traditional MedTechs. However, to stay ahead of the innovation curve, continuous investment in technologies and product development is essential. Established companies often face competition from start-ups that have access to venture capital funding, which enables them to innovate rapidly and take risks that larger, more conventional corporations might avoid due to their scale and existing commitments. To remain competitive, established firms must explore diverse funding sources, including strategic partnerships and government grants, while fostering a culture that encourages calculated risk-taking and agile innovation. This approach can help them maintain a leading position in the ever-evolving MedTech landscape.

Conquering Challenges

We suggest four initiatives to help MedTechs navigate these challenges, foster innovation, improve market responsiveness, and deliver value to customers, thereby driving growth, enhancing value, and increasing competitive advantage.

Innovation Hubs
It is recommended to establish innovation hubs or incubators within the company. These dedicated spaces are ideal for cultivating new ideas and technologies. Creating an environment that encourages creativity and experimentation enables enterprises to accelerate the development of novel solutions and services. Such hubs can also facilitate partnerships with start-ups, academic institutions, and technology firms, creating a collaborative ecosystem that drives innovation.

Agile methodologies
Implementing adaptive methodologies is crucial for speeding up development cycles and enhancing responsiveness to market changes. These practices emphasise iterative progress, flexibility, and close collaboration among team members. Utilising such frameworks allows MedTechs to reduce time-to-market for new products, quickly adapt to regulatory changes, and respond effectively to customer feedback. This adaptability is essential in an industry where technological advancements and market demands evolve rapidly.

Customer Engagement
Enhancing customer engagement through digital platforms, feedback loops, and continuous support is another key strategy. Utilising digital tools enables companies to gather real-time feedback from patients and healthcare providers, ensuring that products and services meet their needs. Creating robust support systems and engaging with customers through various digital channels can foster loyalty and trust. Continuous interaction with end-users helps in refining products and delivering superior customer experiences.

Cross-Functional Teams
Leveraging cross-functional teams is instrumental in driving integrated solutions that combine hardware, software, and services. These teams, composed of members from diverse departments such as R&D, marketing, sales, and customer service, can collaboratively address complex challenges and create comprehensive solutions. Encouraging interdisciplinary collaboration and eliminating silos enables companies to develop more holistic and innovative products and services that meet the needs of the healthcare industry.

Takeaways

The rapid evolution of medical technology markets demands that company leaders balance short- and long-term goals. Increased FDA scrutiny and financial pressures often shift leaders’ focus to immediate concerns, potentially neglecting long-term strategies. Traditional MedTech companies face numerous challenges that require strategic and adaptive approaches to maintain and improve their market position. Cultivating innovation, adaptability, customer engagement, and cross-functional collaboration enables enterprises to thrive in today’s complex healthcare landscape. Prioritising continuous R&D investment, digitisation, and regulatory compliance is essential for staying competitive. Enhancing patient-centric solutions, forming partnerships with start-ups, and attracting top talent are also crucial for driving innovation and market expansion. Embracing innovation hubs, utilising adaptive methodologies, and leveraging cross-functional teams can ensure sustained growth and maintain a competitive edge. Will traditional MedTech companies follow this suggested playbook to create lasting value for patients, shareholders, and the broader healthcare ecosystem or will they stick to their old tricks and hope for the best?

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A Playbook for MedTech Success

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